MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SQ-RX PULSE GENERATOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	1010
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during routine replacement of this subcutaneous implantable cardioverter defibrillator (s-icd), difficulty was encountered with loosening the set screw to remove the electrode from the device header.During attempts to loosen the set screw, the torque wrench became broken and a portion was stuck in the set screw location.A bone cutter was used and the device header was cut.The associated electrode was successfully removed from the device header.This device was explanted and replaced.No adverse patient effects were reported.The product has been received for analysis.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed.Visual inspection noted the header had been removed from the device case, the seal plug was missing, a piece of wrench was confirmed to be stuck in the set screw hex slot and the set screw was in the up position against the retainer washer.The device was returned with no telemetry, however, tones were produced with magnet placement.Laboratory analysis concluded that the position of the wrench piece indicated that the wrench became stuck in the set screw slow after the screw contacted the retainer washer during loosening.Analysis concluded the damage to the device was consistent with induced damage during explant.Representatives from our quality assurance, manufacturing, and design engineering groups are actively investigating this behavior.Our ongoing investigation efforts are currently focused on understanding the root cause to mitigate the potential for setscrew issues when disconnecting the electrode from these s-icds.Information gained through these efforts will be utilized to implement appropriate preventive action(s), as necessary.

• Brand Name: SQ-RX PULSE GENERATOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 229 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16513262
• Report Number: 2124215-2023-11144
• Device Sequence Number: 12353998
• Product Code: LWS
• UDI-Device Identifier: 00802526521300
• UDI-Public: 00802526521300
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/09/2014
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A006760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Female